Comparison of Long vs. Short Acting Anesthesia for Improving Pain Management After Breast Biopsy

Comparison of Long Acting vs. Short Acting Anesthetic Agents as a Tool for Improving Pain Management Post Ultrasound Guided Breast Biopsy

This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast.

Study Overview

• Status: Withdrawn
• Conditions: Pain Management After Breast Biopsy
• Intervention / Treatment: Drug: Lidocaine alone; Drug: Lidocaine Ropivacaine

Detailed Description

The purpose of this study is to evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast. One group of patients will receive lidocaine alone for local anesthesia. A second group of patients will similarly receive lidocaine prior to tissue sampling, followed by infiltration of the biopsy area with ropivacaine.

Our hypothesis is that patients who receive a long acting anesthetic (ropivacaine) along with the popular short acting anesthetic (lidocaine), will be pain free after the breast biopsy procedure for a longer period of time than the patients who only receive lidocaine (the short acting anesthetic). This will lessen the emotional and physical trauma associated with the procedure and give patients a better experience thereby improving patient care.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Mary Jo Cropper Family Center for Breast Care; Bethesda North Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with breast lesions recommended for biopsy by physician

Exclusion Criteria:

• Patients with breast lesions not recommended for biopsy
• Patients with allergic reactions to lidocaine, ropivacaine, or related anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine alone; Lidocaine: 8-10 ml of Lidocaine by subcutaneous injection	Drug: Lidocaine alone
Experimental: Lidocaine Ropivacaine; Lidocaine Ropivacaine; 8-10 ml of Lidocaine given by subcutaneous injection; 8-10 ml of Ropivacaine given by subcutaneous injection	Drug: Lidocaine Ropivacaine; 8-10 ml of Lidocaine given by subcutaneous injection; 8-10 ml of Ropivacaine given by subcutaneous injection; Other Names: Naropin; Ropivacaine HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level from baseline to 1 hour	Amount of pain that patient is feeling at baseline and 1 hour after the procedure	1 hour after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level from 1 hour to 5 hours after procedure	Amount of pain that patient is feeling 5 hours after the procedure	5 hours
Change in pain level from 5 to 10 hours after the procedure	Amount of pain that patient is feeling 10 hours after the procedure	10 hours after procedure
Change in pain level from 10 to 24 hours after procedure	Amount of pain that patient is feeling 24 hours after the procedure	24 hours after procedure
Pathology	Description of tissue collected Benign or malignant tumor (if found) Type of tumor	up to 72 hours after procedure

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Dean Shanley, MD, TriHealth Inc.

Publications and helpful links

General Publications

• Applied Radiology. Breast biopsy: Anesthesia, bleeding prevention, representative sampling and rad-path concordance. Vol 41.1. Jan 2012
• Reynolds HE, Jackson VP, Musick BS. Preoperative needle localization in the breast: utility of local anesthesia. Radiology. 1993 May;187(2):503-5. doi: 10.1148/radiology.187.2.8475298.
• Novy DM, Price M, Huynh PT, Schuetz A. Percutaneous core biopsy of the breast: correlates of anxiety. Acad Radiol. 2001 Jun;8(6):467-72. doi: 10.1016/S1076-6332(03)80617-7.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 7, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Lidocaine; Breast Biopsy; Ropivacaine; Breast Lesion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: 13027-13-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No